Get ready for the Clinical Trials Regulation

By Debbie Pell, Sales Director – New Business

All sponsors, CROs and life sciences organisations supporting clinical trials in the EU will face a major translation challenge in the New Year. That’s because the Clinical Trials Regulation (CTR) comes into application on 31 January 2022.

Primarily, the Regulation intends to harmonise processes for clinical trials throughout the EU with the adoption of the EU’s Clinical Trials Information System (CTIS), a centralised EU portal and database for EU-based trials. In collaboration with the EU member states and the European Commission, The European Medicines Agency (EMA) will maintain the CTIS.

Translations and the Clinical Trials Regulation

Replacing separate national processes, the CTIS will be the single entry point for submitting clinical trial information in the EU to streamline a more efficient process. The Regulation also sees the launch of an EU website with plain language summaries for laypeople, designed to make clinical trials within the EU more transparent.

But, how will this affect sponsors, CROs and healthcare communication agencies with translation procedures? Using the CTIS should mean more efficient outcomes for the industry. However, it also means that if you’re responsible for submitting information through the CTIS you’ll need to be prepared.

A single submission process means that CROs will need to work within tight processes and technology that support these processes. Just as importantly life sciences companies supporting clinical trials will need to work with translation agencies that can are experienced in implementing translation processes and technology so that submissions deadlines are always met.

How to prepare translations for the CTIS

A specialist life sciences translation partner can help you navigate the updated regulations and the CTIS. It is imperative that your translation partner has a proven track record of supporting CROs with new processes and can support you with the following:

• Technology, people and processes to compile several languages in single delivery packages
• Adaptable and flexible operation procedures
• Dedicated key contacts offering regular catch-ups to continuously assess and evaluate efficiency before, during and after transitional changes.

The new CTR requires the publication of a summary of every clinical trial conducted in the EU within one year of trial completion. So you’ll also need to ensure that your translation partner can efficiently translate all ‘Plain Language Summaries’ into every EU language.

Are you and your language service provider ready? Drop us a line! We can provide a free 1-hour consultation on how to ensure your translations will comply with the Clinical Trials Regulation.